Integrating Early Stimulation and Play at Scale: "MAHAY Mikolo"

Early Childhood Development Clinical Trial

Official title:

Integrating Early Stimulation and Play at Scale: "MAHAY Mikolo", a Multi-arm Cluster-randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05129696
• Other study ID #: 2019-08-12476
• Status: Recruiting
• Phase: Phase 3
• Start date: February 1, 2021
• Est. completion date: March 2025

Study information

• Verified date: February 2024
• Source: University of California, Berkeley
• Contact: Lia Fernald, PhD
• Phone: (510) 643-9113
• Email: fernald[@]berkeley.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The overall objective of the study is to examine the effects of integrating early child development group sessions into the existing, at-scale, community health and nutrition programs administered by the government in Madagascar.

Description:

This research is a cluster-randomized trial that will assess the effects of integrating early child development activities on community health worker time use and caregiver time use and participation in the program. The evaluation will compare the addition of early child development sessions to the status quo health and nutrition program, with an additional intervention arm looking at the addition of toys to the program.

This study has four objectives, which will be measured at the community health worker level, and at the caregiver level for caregiver-child dyads (where children are between 6-30 months old at time of intervention launch):

1. Measure how the integration of ECD activities with standard nutrition programming affects the time and task allocation of the community health workers

2. Measure the extent, if any, that the addition of ECD activities crowds out community health worker health/nutrition tasks that are part of the standard community program

3. Measure how the integration of ECD activities affects rates of caregiver participation in nutrition and health activities over time (e.g., during changes in seasonal activities).

4. Measure the impact of enhanced availability and maintenance of age-appropriate play materials/activities on sustained caregiver participation rates in the program.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 8150
• Est. completion date: March 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months to 99 Years

Eligibility

Inclusion Criteria for communities:

1. No other ECD programs present in the community or neighboring communities;

2. At least 40 children monitored at the nutrition center in the target age range of 6-30 months (monitored is defined as attending at least one growth monitoring session between July 2019 to August 2020);

3. Stable supervisory presence. Local NGOs are contracted to monitor and supervise all community health workers and help to strengthen linkages with local structures such as the community health committees and primary care facilities. Each NGO supervisor is in charge to up to 9 communities, which they visit twice a month. The investigators defined stable presence as not having had NGO turnover within the last year.

Among the communities included, children 6-30 months were eligible to participate in the intervention. There was no inclusion criteria for community health workers.

Related Conditions & MeSH terms

• Early Childhood Development

Intervention

Behavioral:
• Treatment (T)
Children area offered to participate in bimonthly group sessions. Each session will have materials and activities appropriate for children spanning a 6-month range (6-12 m, 12-18 m, 12-24 m, 24-30 m) and can accommodate a maximum of 10 children per age group. If more households are interested than can be accommodated by the program, interested families will be randomly selected for participation. A total of 40 children per site will be able to participate in the ECD activities at any one time. With bi-monthly meetings, each child will be exposed to 12 sessions for each age group, and is eligible to transition to the next.
• Treatment + (T+)
Caregivers/children participating to the group ECD sessions will be invited to play within a play space equipped with books, and homemade/purchased age-appropriate toys. This will be phased in after 6 months of implementation.

Locations

Country	Name	City	State
Madagascar	L'Office National de Nutrition (ONN)	Antananarivo

Sponsors (4)

Lead Sponsor	Collaborator
University of California, Berkeley	L'Office National de Nutrition, Madagascar, University of Nevada, Reno, World Bank

Country where clinical trial is conducted

Madagascar, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Community health worker time use	Proportion of working day spent on community health worker activities, measured through recall of hourly time use using monthly phone surveys	Up to 12 months
Primary	Caregiver-child attendance in health and nutrition sessions	Monthly attendance in health and nutrition sessions, measured through session attendance records (0 = Did Not Attend, 1 = Attended)	Up to 12 months
Primary	Caregiver-child attendance in ECD group sessions	Monthly attendance in ECD sessions, measured through session attendance records (0 = Did Not Attend, 1 = Attended)	Up to 12 months
Secondary	Community health worker stress	Perceived Stress Scale 4 (PSS-4) administered monthly (Low: 0, High: 16, Higher scores are correlated to more stress)	Up to 12 months
Secondary	Community health worker depressive symptoms	Center for Epidemiologic Studies Depression Scale-10 (CESD-10), administered quarterly (Low: 0, High: 30, Higher scores indicate worse symptoms)	Up to 12 months